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Combined Treatment for Cocaine-Alcohol Dependence - 1
This study has been completed.
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218569
  Purpose

The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.


Condition Intervention Phase
Alcohol Dependence
Cocaine Dependence
Drug: Naltrexone
Drug: Placebo
Phase II

MedlinePlus related topics: Alcoholism
Drug Information available for: Naltrexone 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Naltrexone hydrochloride Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Combined Treatment for Cocaine-Alcohol Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Urine toxicology for cocaine [ Time Frame: 12 weeks of study ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: April 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Naltrexone
Drug: Naltrexone
Naltrexone
2: Experimental
Placebo
Drug: Placebo
Placebo

Detailed Description:

This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence. Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP). Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits. Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions. CMP will be based on cocaine-negative urine screens and negative breath alcohol tests. Follow-up assessments will be conducted at 3 and 6 months after treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Give informed consent
  • Be able to understand the nature of the study, agree to comply with study requirements, report regularly for scheduled visits, and communicate with study personnel about adverse events and concomitant medication use
  • Be between 18 and 60 years old
  • Meet DSM-IV criteria for both current cocaine and alcohol dependence
  • Be in acceptable health based on physical exam, lab tests, and EKG
  • Have a stable living situation and the availability of at least two locators
  • Be able to read and write English at the 6th grade level
  • Provide a least one cocaine positive urine during intake
  • If female, must agree to use contraception

Exclusion Criteria:

  • History of evidence of a medical condition that would expose them to an undue risk or interfere with assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, or neurologic disease as determined by the clinical judgment of the research team
  • Medical condition that is contraindicated with opioid antagonists or necessitates opiate medication
  • Abnormal liver function test results (both ALT and AST >3x upper limit normal or either >5x upper limit normal)
  • Currently in treatment or have received treatment in the past six months for substance abuse or another psychiatric condition
  • Evidence of a Axis I disorder that will interfere with the course of the trial, including but not limited to current Major Depressive Disorder, Bipolar Disorder, Panic Disorder, Schizophrenia, Bulimia nervosa or Anorexia, and Post-traumatic stress disorder as determined by the clinical judgment of the research team
  • Participating in 12 step meetings more than twice weekly
  • Opiate abuse or dependence in the last five years or used opiates, barbiturates, benzodiazepines in the last thirty days
  • Current dependence on any psychoactive disorder other than nicotine
  • Impending incarceration
  • Condition of probation or parole requiring reports of drug use to officers of the court
  • Women of child bearing potential must not be pregnant/lactating or unwilling to use an acceptable contraceptive method
  • Plans to move from the Houston area within the next three months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218569

Locations
United States, Texas
University of Texas Health Sci Cntr Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Joy Schmitz, Ph.D. The University of Texas Health Science Center, Houston
  More Information

Responsible Party: University of Texas Medical School at Houston ( Joy M. Schmitz, Ph.D. )
Study ID Numbers: NIDA-15801-1, R01-15801-1
Study First Received: September 20, 2005
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00218569  
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Alcohol Dependence
Cocaine Dependence

Study placed in the following topic categories:
Cocaine-Related Disorders
Dopamine
Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Cocaine
Ethanol

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009